Vibrating dental devices

ABSTRACT

A variety of improvements to the vibrating devices for dental remodeling are provided, including improved bite plate designs that accommodate common patient bite structure, a connector for a bite plate, a sizing tray for same, as well as better motors providing improved performance characteristics for an extraoral vibrator, and a completely intraoral vibrating dental plate with very thin cross section.

PRIOR RELATED APPLICATIONS

This application is a Continuation of Ser. No. 12/615,049, filed Nov. 9,2009, which is a Continuation-in-Part of US2008227046 (Ser. No.11/773,849), filed Jul. 5, 2007, which claims priority to 60/906,807,filed Mar. 14, 2007. Each of these is incorporated by reference in theirentirety.

FEDERALLY SPONSORED RESEARCH STATEMENT

Not applicable.

REFERENCE TO MICROFICHE APPENDIX

Not applicable.

FIELD OF THE INVENTION

The invention relates to vibrating dental devices for correctingmalocclusion.

BACKGROUND OF THE INVENTION

Orthodontics is a dental specialty that treats malocclusion through themovement of teeth as well as control and modification of facial growth.This process is usually accomplished by using a continuous mechanicalforce to induce bone remodeling, thereby enabling the teeth to move to abetter position. In this approach, orthodontic appliances provide acontinuous static force to the teeth via an archwire connected tobrackets affixed to each tooth or via a removable appliance such as analigner, or some similar accessory, that fits over the dentition. As theteeth slowly move due to the force, the force is dissipated. Thearchwires are adjusted to add additional force and to continue thedesired tooth movement. Although effective, this widely acceptedapproach takes about twenty four months on average to achieve success.

Dental researchers have long postulated that a pulsating force mightalso be used to move teeth more rapidly and to ease the discomfort oftraditional orthodontics.

Mao was probably the first to prove that the use of cyclic forces couldimprove dental straightening in rabbits (see U.S. Pat. No. 6,684,639,U.S. Pat. No. 6,832,912, U.S. Pat. No. 7,029,276). Certain dynamicloading patterns (cycling force with rest periods) were shown to greatlyincrease bone formation compared to basic dynamic loading. Insertingrest periods is now known to be especially efficacious as it allowsmechanosensitivity to be restored to the bone tissue. A point ofdiminishing returns is reached within each loading session. Therefore,intermittently loading cyclic force can increase the rate of boneformation significantly.

U.S. Pat. No. 4,244,688, U.S. Pat. No. 4,348,177, and U.S. Pat. No.4,382,780 describe devices used to vibrate the teeth during orthodontictreatment, although each uses a different means of applying a vibration.The U.S. Pat. No. 4,244,688 patent employs a cumbersome external powersource to power one to four small motors, whereas U.S. Pat. No.4,348,177 uses pulsating fluids moved with the chewing motion of thejaw, and U.S. Pat. No. 4,382,780 uses a radio and speaker to set up avibration. These devices are mounted on a bulky headgear that surroundsthe head and are connected directly to the teeth by its intraoralportions. The devices are cumbersome, difficult to construct, expensiveand are very difficult to use, thus reducing patient compliance.

U.S. Pat. No. 5,030,098 by Branford describes a hand-held device thatsimulates chewing in order to treat periodontal disease by increasingblood flow to the gums. The mouthpiece has a perforated malleable platesuch that biting of the mouthpiece results in the plate adapting to theuser's bite which, of course, varies with each user. The externalvibrator imparts motion to the mouthpiece and thus the user's teeth. Thedevice, however, uses an external power source and vibrator. Further,the dental plate is brass, and is very unpleasant to bite on, thusnecessitating a second exterior coating and further complicatingmanufacture and cost.

U.S. Pat. No. 5,967,784 by Powers describes a similar device to thatdescribed by Branford. It too is a hand-held tooth vibrator that issimple and has an exterior motor housing connected to a vibratinginterdental mouthpiece portion for gripping between the teeth of thepatient. The exterior housing contains a battery and a switch forselectively operating a motor with an off-center weight attached to themotor rotating shaft for creating a high frequency vibration thatvibrates the entire device. The mouthpiece is disposable, making thesystem affordable and more convenient to use. The patent teaches usingthe device to alleviate pain by inserting the interdental mouthpiecebetween the teeth and clenching and releasing the teeth over themouthpiece, in an attempt to engage as many teeth as possible in thetransmitted vibrations. The vibration is believed to alleviatediscomfort by increasing blood flow.

The devices of Branford and Powers seem superficially similar to thoseof the invention herein. However, there is no recognition in eitherpatent that the vibratory device can be used for alveolar boneremodeling or more rapid tooth movement. Furthermore, the shape of thedental plate in each case is a very flat U- or Y-shaped member that islargely ineffective for remodeling dentoalveolar bone. Additionally, thevibration is not optimized in frequency and amplitude for remodeling.Finally, neither device is entirely intraoral, and the extraoralcomponent may cause drooling and inhibit patient compliance. Theextraoral component may also lead to inhibition about use of the devicein certain settings. All of these shortcomings reduce the effectivenessof these devices for craniofacial remodeling uses.

U.S. Pat. No. 6,632,088 describes a bracket with powered actuatormounted thereto to provide vibration, but this device is cumbersome, andthus may affect patient comfort and ultimately patient acceptance of thedevice. Further, the device locks to the bracket and archwire, andvibration of the tooth through the bracket is less than optimal, causingwear to the tooth enamel and causing discomfort.

WO2007116654 describes another intraoral vibrating mouthpiece, but themouthpiece is complex, designed to fit over the teeth and will beexpensive to manufacture. Further, to the extent that this devicevibrates the brackets, it suffers from the same disadvantages above.

SUMMARY OF THE INVENTION

The invention generally relates to improved devices for dentalremodeling through the application of cyclic forces. There are four mainembodiments herein described as well as several variations thereon: 1) avariety of bite plate designs to accommodate common patientmorphologies; 2) an improved extraoral vibrator with improvedperformance characteristics; 3) a bite plate connector; and 4) acompletely intraoral bite plate.

In a first embodiment, the invention is an improved bite plate designthat accommodates the various bite configurations that a patient mayhave. Thus, a wedge-shaped bite plate sloping with increased verticaldimension from anterior to posterior is provided for patients with adeep-bite malocclusion; a wedge-shaped bite plate sloping with increasedvertical dimension from posterior to anterior is provided for patientswith an open-bite; and a flat bite plate is provided for patients withmalocclusion that does not involve an open-bite or deep-bite (see alsoFIG. 1).

In a second embodiment, the improved extraoral vibrator has a morestable vibrator with improved performance characteristics of decreasedsound and low variability frequency and force. In particular, theimproved vibrator has a noise level less than 55 dB when measured at 6inches, a frequency at 20-40 Hz, with a variance of only 2 Hz, and aforce of 0.1-0.5 Newtons, with a variance of ±0.05 N.

In preferred embodiments, vibrating dental devices have the capabilityof recording device usage and reporting same to the dental professional.Preferably these communications are wireless, e.g., via Bluetooth®, butcan also be wired, and the communication can occur in the dentalprofessional's office or via the internet. In another embodiment, thedental professional (and possibly patient) has the ability to modulatefrequency, force, and which vibrators are used, as needed for patientswith sensitivity to a high frequency X force combinations, and who needto vibrate certain teeth and omit others. Designing circuitry andprogramming for achieving these goals is well within the art, and isfurther described in US2008227046.

In other embodiments, the bite plate contains a chip with a short soundrecording, such as is found in greeting cards and toys. The recordingcan be activated with, e.g., a depressible switch, and can bepre-recorded to indicate e.g., plate size, or can be recorded by thedental professional with e.g., a short message for the patient.Alternatively, plate size can be included on a chip within the platewhich then can be read with a scanner, e.g., as is done with RFIDscanners.

In other embodiments, the external housing of any dental device iscustomizable by printing thereon particular colors and/or designs, asspecified by each customer. Alternatively, a reasonable range of colorsand text or logo printing options may be available from which thecustomer can choose.

In other embodiments, the each device is printed with a unique serialnumber and/or bar codes to allow for device tracking.

In a third embodiment, an improved connector is provided for connectingthe bite plate to an extraoral vibrator, wherein the connector isasymmetric and thus prevents the user from inserting the plate upsidedown. The connector comprises a flare at the midline of the bite platewith depressions therein so that the matching protrusions on thevibrator fit thereinto. The depressions are offset from the central axisof the connector, thus the connector cannot be accidentally insertedupside down. The flare has a cylindrical shaft protruding therefrom forinsertion into an appropriately shaped receptacle on the vibrator. Theshaft has matching pins or protrusions on each side of the shaft, at theend near the bite plate, and there are corresponding depressions in thereceptacle on the vibrator. This particular connector is a snap fitconnector, configured so that only manual force is needed to insert andremove the bite plate. The snap fit in this instance is accomplishedwith a groove on the cylindrical shaft into which a circular spring inthe vibrator will fit into. The application of a small amount of forcestretches the spring slightly, allowing the device to be removed.

In a fourth major embodiment, the invention generally relates to acompletely intraoral vibrating dental plate, wherein the entire deviceis contained in a thin, roughly planar, dentition shaped plate, and ishermetically sealed. All intraoral bite plate embodiments may becombined with the improved bite plate designs shown and discussed inFIG. 1. In its simplest embodiment, one or more vibrators are mounted ona bite plate and hermetically sealed. The device is then wirelesslyactivated with an external power source, such as that described inUS2009058361 and all programming components are also external.

In another embodiment of the intraoral device, a battery is also placedon the bite plate, together with on/off switches on the plate, which canbe, for example, activated by biting the plate.

For patient comfort, the smallest means of providing vibration areemployed on the intraoral device. A large number of very small vibratingmotors are available, as shown in the table below, but piezoelectricmotors may be preferred due to the small size, and off-set weightedmotors may be preferred due to low cost and availability. Particularlypreferred are the substantially planar motors where the vibration issubstantially parallel to the substrate (e.g, U.S. Pat. No. 5,554,971,U.S. Pat. No. 5,780,958, US2009224616, US2008129130, US2007103016,WO0178217, each incorporated by reference).

Company Catalog Size Specifications ELLIPTEC AG ™ NA 10 × 3 × 2 mm 3-6volts See U.S. piezoelectric Pat. No. motor 6,870,304 SURPLUS MF820 8 ×4 mm 1.5 to 4.5 VDC TRADERS ™ (0.315 × 0.1575 weighted shaft inches)SURPLUS MF918 0.45 × 0.16 inches 1 VDC to 5 VDC TRADERS ™ 18 ohmsWeighted shaft MOTOROLA ™ G13566 0.44 × 0.18 inches 1 VDC to 9 VDC 10ohms Weighted shaft SURPLUS MF835 0.45 × 0.24 inches 1.3 Vdc TRADERS ™100 mA Weighted shaft MATSUSHITA ™ V0296A 0.24 inch diameter 1.5 VDCWeighted shaft SURPLUS ME235 0.24 × 0.5 inches 1.5 to 3 VDC TRADERS ™ 62mA weighted shaft PRECISION 304-002 4 m × 8 mm 2.3 VDC to MICRODRIVES ™3.6 VDC 100-120 mA 11000 rpm Weighted shaft PRECISION 308-100 3.4 × 82.-3.3 V, 120 mA MICRODRIVES ™ 12000 rpm 8 mm Shaftless Vibration Motor

In addition to electromagnetic motors and piezoelectric motors, othermotor types can be used including mechanical actuators, ultrasonicmotors and the like. Vibrations may be oscillating, random, directional,circular, and the like. Vibrators are well within the skill of the art,and several are described in the patent literature (and commerciallyavailable as seen above). For example, US2007299372, US2007255188,US2007208284, US2007179414, US2007161931, US2007161461, US2006287620,each incorporated by reference, describes various vibrator motors.

Batteries may drive the vibrational source for some intraoralembodiments. Small coin batteries, alkaline or lithium, are preferreddue to their small size, but hydrogen batteries may also be preferreddue to their power and power density, particularly as size and costdecrease with further technological development.

For certain embodiments, a battery that can be wirelessly recharged ispreferred for longer product life (e.g., US2009051312, U.S. Pat. No.7,511,454), but in other embodiments a low cost device is manufacturedthat is intended to be disposable. It is known in the art to select anappropriate power source/motor combination to provide an orthodonticvibrator that vibrates within the frequency and power suitable fororthodontic remodeling.

Any off the shelf on/off switch can be used. Particularly preferred forthe intraoral device is an on/off switch with depressible activator(push button or rocker).

Generally speaking, the vibrator(s), and optional battery, on/off switchand circuitry are placed directly on the bite plate and hermeticallysealed with no extraoral protrusions, thus allowing the most compactbite plate, preventing drooling and maximizing patient compliance. Inpreferred embodiments, the core may contain depressions therein forfitting various components thereinto, thus maintaining the generallyplanar surface of the bite plate and maintaining a thin cross section.

The bite plate (whether for the intraoral embodiment or not) should havean average thickness of less than 10 mm and preferably is less than 7,5, 4 or 3 mm. The various components (if any) can be placed anywhere onthe bite plate, but preferably the switch is positioned near the molars,where good contact with teeth is easily made, and the vibrators arebalanced on each side of the plate.

One or more vibrators can be placed on the plate, e.g., one on eachside, or one for each of three tridents or four quadrants, as shown inFIG. 5. Where more than one vibrator is used, the vibrators should besynchronized when in use, so that the vibrations do not cancel eachother out. In the alternative, the various portions of the bite platecan be separated with a thin divider portion of elastomeric materialthat serves to dampen the vibration and prevent its transfer to anotherportion of the bite plate. Either embodiment can be provided withcontrol circuitry to either synchronize the motors, or to use the motorsindividually, thus vibrating only certain teeth.

The dental plate itself generally contains a stiff core, such as metalor rigid plastic onto which are placed the vibrator, and optional on/offswitch, battery and the circuitry, as needed to run the device. Otherstiff core materials can also be employed including ceramic, polymersand resins. However, aluminum and steel are preferred as easy to workwith, inexpensive and having some flex, although certain plasticmaterials, such as polycarbonate, may be preferred as inexpensive andeasily molded to fit components.

The dental plate can then be covered with a liquid-tight, elasticpolymeric material to protect the user's teeth from the metal, toisolate any electrical components, and to provide a biocompatible andpleasant mouth feel. This is important for an intraoral embodiment, butthe coating is optional on an extraoral device. Coatings, such assilicone rubber, polyethylene (PE), high density PE (HDPE),polycarbonate, polyurethane, polypropylene (PP), polyvinylchloride(PVC), polymethyl methacrylate, polyvinylidene fluoride, polyesters,acrylics, vinyl, nylon, rubber, latex, Teflon, or similar material, andcombinations thereof may be used.

Preferably, the coating will not have an objectionable taste and will beFDA approved, such as silicone rubber, polypropylene, HDPE, and thelike. In another embodiment the bite plate coating and other parts ofthe appliance that contact oral tissues have a selection of flavoringsfor additional comfort in use of the appliance. In yet anotherembodiment, the device is coated with a polymer that can be reshaped forcustom fit, such as boil and bite polymers, or polymers that can beactivated, cured and/or set with the addition of light and/or chemicals.

Depending on which teeth or regions of dentition that need to betreated, different dental plate shapes are possible. However, generally,the dental plate is flat to allow contact of the occlusal surfaces ofall teeth when the dentition has reached a final level plane andU-shaped. Alternatively, the dental plate may cover only a portion ofthe dentition, thus being restricted to fewer teeth in use anddifferential tooth movement as a planned treatment approach. The dentalplate can also have one or more vertical edges or phalanges(perpendicular to the midline when positioned inside the mouth), saidedges being positioned to contact the facial and lingual surfaces of theteeth and possibly even apically beyond the gum line, thus providingincreased circulation to the gums. In preferred embodiments, the dentalplate has a U-shaped bite plate, and is slightly tapered to be thinnerin the back of the mouth to accommodate the hinged nature of the teeth.In other preferred embodiments a series of bite plates such as describedin FIG. 1A-D are provided.

A series of bite plates for sizing a patient's bite are also provided.For example, the six bite plates of FIG. 1 can be packaged into a sizingkit for dental use. The sizes can be labeled thereon, or the plates canbe color coded or otherwise distinguished with visible markings.Alternatively, as described above a chip containing size information canbe read by scanner, or a sound recording can be activated to indicatesize information. The sizing tray can contain any number of differentsizes including 2, 3, 4, 6, 8, 10 and higher. Preferably, the sizingtray is shaped to display the bite plates in a horizontal configuration(U-shape showing) and allow any fluids, as used during the sterilizationor disinfection process, to drain from the surface of the bite plate.

The devices can be used alone, or in combination with other orthodonticdevices. In some embodiments, the appliance can be used to speed boneyremodeling in orthodontic uses with traditional orthodontic fixedappliances or aligner based treatments or any other appliance used fortooth movement. In other embodiments the appliance can be used toenhance boney remodeling in periodontal and oral surgical uses.

The device of the invention can be used in a variety of oral andmaxillofacial applications including malocclusion, trauma repair,temporomandibular joint and muscle disorders (TMJDs), Lefort and otherskeletal facial fractures, craniofacial anomalies such as boney clefts,bone defects, dentofacial deformities, dental implants, periodontal bonegrafts as well as tooth, muscle, nerve, tendon, ligament, bone, andconnective tissue repair.

Thus, the invention also includes a method for movement of one or moreteeth by applying differential vibration to selected areas of a biteplate at frequencies between 1 to 1000 Hz (preferably 10-100 Hz and mostpreferred 20-40 Hz) and a force of 0.01-2 Newtons (or 0.1-0.5 or 0.2Newtons) for a period of 1-60 minutes, preferably about 1-30 or 1-10minutes or 20 minutes. This is followed by a period of recovery, rangingfrom 2-24 hours, preferably from 4-12 hours, and the cycle is repeateduntil one or more teeth are successfully moved. More particularly, theorthodontic appliance of the invention has a vibrational source capableof providing a vibratory force at a frequency of between 20 to 40 Hz or30 Hz and a force of 0.2 Newtons. Excess force is generally unpleasantto the patient, especially force coupled with high frequency, and inpreferred embodiments these parameters are adjustable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A-D. Improved bite plate designs accommodating deep, flat and openbites.

FIG. 2A-D are perspective views of the bite plate with connector forattachment to extraoral vibrator. FIGS. 2A and 2B are the inner core andclear polymeric overcoat, in this prototype Versaflax CL2250. Also,shown in FIGS. 2C and 2D is an inner core without the coating.

FIG. 3A-D are line drawings of the bite plate and connector, showing aflare, a shaft, pins and depression, groove and the spring that fitsinto the groove.

FIG. 4A-B show sizing details of the connector of FIG. 3.

FIG. 5A-C show an intraoral bite plate in several views. FIG. 5A is aperspective view of the core with battery, on/off switch and vibrators,where the hermetically sealed coating is omitted for clarity. FIG. 5B isa side view with clear coating. FIG. 5C is a top view of an embodimentshowing polymeric dividers between various portions of the bite plate todampen the vibration between the segments (vibrator and other componentsomitted for clarity).

FIG. 6A-B provides basic dental nomenclature and is for referencepurposes only.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The following examples are illustrative only and not intended to limitthe invention.

Example 1

The improved mouthpieces or bite plates are available in two sizes(small and large) based primarily on the anatomical dimensions of thepatient's dental arches. Each size is available in three profiles basedprimarily on the type of malocclusion (open bite, deep bite and normalflat plane occlusion).

In the bite plates shown in FIG. 1, the phalanges that contact thelingual and buccal (inside and front) surface of the teeth are omittedfor clarity, but such phalanges or edges are preferred since these edgesallow greater contact with the teeth for improved comfort and improvedtransmission of the cyclic forces. Also shown in FIGS. 1A-D (but notlabeled) are optional ridges on the surface of the bite plate.

The sizes and profiles have been developed based on a statisticalanalysis of a sample population and are intended to allow for a maximumcontact of teeth with the bite plate in a high percentage of patientsand case types. The dimensions given in Table 1 are based on a minimumthickness E of 3.0-3.1 mm for the bite plate and based on using 6 sizesto fit most members of an average patient population. Obviously thefinal dimensions will change if the minimum thickness is changed (e.g.,in an intraoral embodiment the thickness may increase to accommodatemechanical and/or electrical components), and customized bite plates maybe required for outliers.

Generally speaking, the bite plate is U shaped, and can optionally havea connector at the midline to provide for secure attachment to anextraoral component. E represents the minimum thickness of the biteplate and ranges from 1-10 mm and preferably 2-5 mm or about 3 mm as inTable 1.

The thickness E increases from the ends of the U (where the molars wouldbe when in use) towards the midline D (where the front teeth would bewhen in use) for use in patients having an open bite, and ranges from Eto D=E+0.5-10 or more preferably 1-3 mm.

In the bite plate for the patient having a flat bite, the thickness Edoes not vary substantially from the molars to the anterior teeth.

For the patient having a deep bite, the bite plate is generally thickerat the molars (ends) than at the front (midline) (not shown) by 0.5-10mm. Alternatively, the deep bite plate may have two portions ofdifferent thickness with the thicker portion being at or near the endsand the thinner portion at or near the front, but not vary within eachportion (not shown). In one preferred embodiment, the thickness Eincreases 0.5-10 mm (or 1-3 mm) from the ends towards the middle, butthen narrows and again is roughly flat at the front to accommodate the4-6 anterior teeth.

The exterior width (perpendicular to the midline) of the U-shaped biteplate ranges from 62-70 mm and the length (along the midline) rangesfrom 51-53 mm. More particularly, the U shaped plate also has aninterior width B between the ends of the U and an exterior width A thatincludes the width of the bite plate ends. Further, the bite plate has alength C from the ends to the base of the U. In the small bite plate,the interior width B is 30-32 mm and preferably 31.8-31.9 mm, and theexterior width A is 61-63 mm, preferably 62.6-62.7 mm. The length Cranges from 51-53 mm, preferably 52.1.-52.4 mm. In the larger biteplate, B is 36-39 or about 37.7, A is 68-70 or 69.9-70, and C is 51-52or 51.5-51.9.

TABLE 1 Optimal bite plate dimensions all sizes in mm Small Large OpenDeep Flat Open Deep Flat Bite Bite Bite Bite Bite Bite A 62.6 62.6 62.769.9 69.9  70.0 B 31.9 31.9 31.8 37.8  37.8 v 37.8 C 52.1 52.4 52.1 51.951.9  51.5 D 5.3 3.5 4.4 5.3 3.5 4.3 E 3.1 3.1 3.1 3.1 3.1 3.0

In general, the bite plate should be the smallest size possible forpatient comfort without impinging on the cheeks, tongue and/orinterfering with orthodontic appliances. During the course oforthodontic care the patient may require additional bite plates due towear, change in occlusion (particularly as the treatment plan correctsmaligned dentition), or continued craniofacial growth. Therefore, thefit should be reevaluated at adjustment visits, particularly if thepatient complains of poor fit or discomfort.

The bite plates can be sterilized using chemical or autoclaving methodsas follows: 1) using full strength Centra Cidex 7 at room temperaturefor 10 hours; 2) Steam Sterilization with pre-vacuum: 3-4 minutes at270° F. to 274° F. (132° C. to 134° C.) and 28-30 psi (193-207 kpa); 3)Steam Sterilization with gravity displacement: 20-30 minutes at 250° F.(121° C.) and 15-17 psi (104-117 kpa). Alternatively, only the sizingplates may be manufactured so as to withstand sterilization, and thecustomer bite plates can be of different materials.

Example 2

In a second embodiment, an improved extraoral vibrator has a more stablevibrator with improved performance characteristics of decreased soundand low variability frequency and force. In particular, the improvedvibrator has a noise level less than 55 dB when measured at 6 inches,and preferably less than 50, 45, 40, or 35 dB. The improved vibratorprovides a frequency at 20-40 Hz, preferably 30 Hz with a variance ofonly 2 Hz, and preferably 1 or 0.75 Hz. This is particularly importantwhere the patient may move around during use, whereby lower qualityvibrators may vary substantially with motion and/or orientation and thusprovides an inconsistency that may be less efficacious, and may make FDAclearance of such a device more difficult. Further, the improvedvibrator provides force at 0.1-0.5 Newtons, and preferably at 0.20Newtons (20 grams) with a variance of ±0.05 N, and preferably less than±0.03 N.

Consistency of frequency and force is achieved herein via a feedbackloop whereby motor speed is monitored and software adjusts the motor asneeded. More particularly, the motor contains an integrated encoder thatprovides multiple high and low signal outputs per every motorrevolution. The software counts the time between every encoder event andcompares this to the desired target (e.g., 30 Hz). Based on thiscomparison, the software then adjusts the pulse width modulation that isdriving the motor to increase or decrease speed as appropriate tomaintain the desired speed. Accurate controlling of speed also controlsthe force.

A DC 6V Motor having off-set weight and 8 line integrated encoder isknown to provide these characteristics, but other vibrators may alsoprovide these performance characteristics, and can be easily tested forsame. Preferably the battery is a chargeable 100 mAh Li battery.Preferably, the motor is the Series 1506 DC Motor, by MicromoElectronics, Inc. (Part No. 1506N006SRIE2-8), and the battery is a 100mAh Li—PO battery by Harding Energy (Part no. BAN-E601421).

Another improvement on the extraoral vibrating device is the provisionof a charging stand that serves to dock the vibrator and charge it atthe same time. The charging station also has a display and software sothat the user can see the usage data. Thus, a dental profession (orparent) can determine whether the patient is using the device asintended. In one embodiment, the display shows the number of uses perweek (for example 6/7=86%), the number of uses per month (25/30=83%))and the total number of uses (145 uses).

Example 3

The bite plate of FIGS. 2A-D show the substantially U shaped bite plate1 with clear overcoat 3 covering a stiff inner core 5 (shown as solid).Also shown is the lingual phalange or edge 7 for contacting the lingualsurfaces of the teeth, in this instance only the front or anterior teeth(see labial area of FIG. 6A), and facial phalange 9 for contacting thefacial surfaces of the teeth, as well as connector 2. The phalangesprovide additional force transferring contacts with the teeth, but alsoaid in maintaining the correct position of the bite plate during use.Without the phalanges, the bite plate will vibrate away from the optimalposition during use.

FIGS. 3A-D show the details of the bite plate of FIGS. 2A-D, and FIGS.4A-B includes sizing details of a preferred embodiment of the connector.In a basic configuration the connector 21 is a snap fit connector havinga cylindrical shaft 23 that fits into a socket or receptacle on thevibrator. The shaft is of diameter 6-7 mm and preferably 6.35 mm (+0.03,−0.10). Further the shaft length is 5-15 mm, and preferably about 8-12or 10.25 mm. In a preferred embodiment, the shaft is beveled at the endthat fits into the socket to allow for easy insertion (not shown). Agroove 25 in the shaft provides the snap fit, wherein a protrusion inthe socket snap fits into the groove. The groove is of width >1.4 mm,and depth ≧0.4 mm, and preferably is of width 1.65 mm and depth at least0.4 mm, and preferably 0.425 mm (diameter at the groove is 5.5 mm). Thegroove is positioned approximately midway (35-65%) along the groove, inthis instance 4 mm from the bite plate end of the shaft. However, thisdistance from either end of the shaft can be modified somewhat,depending on the length of the shaft, and yet the connector will stillfit into the same socket.

In this case, we designed a circular coil to spring fit into the groove,as shown, but any appropriately placed protrusions in the socket willsuffice, including a protrusion that completely encompasses thecircumference of the socket, or two or more small protrusions along thecircumference of the socket and in alignment with said groove (notshown). It is known in the art to vary the stiffness of the spring toprovide the appropriate degree of tension so that the bite plate is notinadvertently dislodged, yet is easily removed by the patient or dentalprofessional.

Other features of the connector are shown, including pins on either sideof the connector, and a flare between the shaft and the bite plate whichhas two depressions off center from the axis of the shaft in order toprevent the bite plate from being inserted in the incorrect orientation.However, each of these features is exemplary and can be varied widely.For example, the protrusions (pins) and depressions can be varied innumber, placement and size, and the flare is optional or can bedifferently shaped. Preferably, the flare is shaped for easy handlingwith the thumb and fore finger and thus has the dumbbell shape as shown.

Example 4

The intraoral device 111 of FIGS. 5A-C illustrate the core 11 having abattery 31, on/off switch 51, and two vibrators 71. The same device isshown in side view with the clear polymeric coating 91 to form thecomplete intraoral vibrating dental plate. The minimum intraoral devicehas an intraoral motor, and is activatable wirelessly (not shown). Thus,the battery and switch can be omitted. However, battery and variouscontrollers can also be provided directly in the device as shown.Further, circuitry can be added to allow this device to store usageinformation and communication wirelessly with an external controller(not shown).

Another view in FIG. 5B shows an embodiment wherein segments of theinner core 11 (here shown three) are separated by portions of apolymeric material that serves to dampen vibration from one segment tothe other, allowing the dental professional to vibrate 2, 3, 4, 5 or 6segments of the device individually, thus customizing treatment for eachpatient. In this instance, the polymeric overcoat that seals the deviceis sufficiently soft and elastomeric to also provide the dampeningfunction and thus the same material meets both needs. In otherembodiments, two or more different materials are used.

In those embodiments where an external controller is provided for theintraoral bite plate, the controller or processor can provide one ormore of the following functions: 1) wirelessly power and activate thevibrators; 2) differentially activate multiple vibrators; 3) synchronizemultiple vibrators to have the same frequency and timing; 4)differentially control multiple vibrators to provide different forces;5) wirelessly charge an internal battery; 6) wirelessly download anddisplay usage information (or transmit such information to an externaldisplay); and 7) wirelessly identify the size of the plate. Preferably,the controller has a display and is programmed to provide the dentalprofessional with a variety of usage options via a menu and/or dataentry fields, but these functions can also be provided with yet anotherprocessor (e.g, a laptop computer) having increased display space andcomputing power, and the initial processor merely serves as a dedicatedinterface between the two.

Example 5

A pilot clinical study was performed by Chung How Kau, B D S, PhD withan extraoral vibrator and bite plate, as described herein. The study wasconducted with 17 subjects, 14 of whom completed the study. Subjectswith a Class I malocclusion and at least 6 mm of lower anterior crowdingwere provided with the device and instructed to use it for 20 minutesdaily for six months during orthodontic treatment. Other selectioncriteria for the study included estimated level of compliance with useof the device in accordance with the instructions and good oral hygiene.Several subjects also required extractions and space closure.

Although compliance varied from patient to patient, patients reportedusing the device about 80% of the time, while the device microcomputerdocumented an average of 67% usage. No adverse events were reportedduring the study, and most patients watched television, listened tomusic, or played video games while using the device. The most commonword used to describe device use was “easy.”

A cone beam device (GALILEOS,™ by SIRONA™) was utilized to accuratelymeasure tooth roots and to estimate any resulting root resorption, withimaging in all three planes (sagittal, axial and coronal views). Thestudy was designed to determine if any root resorption greater than 0.5mm occurred or if there were alterations in root lengths, and nosignificant losses were found.

The study also measured distances between teeth using a digital caliper.The overall distance in millimeters between the front five teeth, bothupper and lower, was calculated during the alignment phase. The gapbetween teeth due to extractions was measured directly. The overallmovement rate during the study was 0.526 mm per week, which is higherthan average movement without the device.

We conclude that the device increases the rate of orthodontic toothmovement and can be used with either fixed orthodontic appliances orclear aligners, offering flexibility. This is useful given the mix oforthodontic therapies available and particularly since some patientshave combination therapy utilizing both fixed orthodontic appliances andclear aligner therapy. Short-term daily use for 20 minutes provides anadvantage for patients.

The following references are expressly incorporated in their entirety:

-   US2006287620-   US2007103016-   US2007161461-   US2007161931-   US2007179414-   US2007208284-   US2007255188-   US2007299372-   US2008129130-   US2008227046-   US2009051312-   US2009058361-   US2009224616-   U.S. Pat. No. 4,244,688-   U.S. Pat. No. 4,348,177-   U.S. Pat. No. 4,382,780-   U.S. Pat. No. 5,030,098-   U.S. Pat. No. 5,554,971-   U.S. Pat. No. 5,780,958-   U.S. Pat. No. 5,967,784-   U.S. Pat. No. 6,632,088-   U.S. Pat. No. 6,684,639-   U.S. Pat. No. 6,832,912-   U.S. Pat. No. 6,870,304-   U.S. Pat. No. 7,029,276-   WO200178217-   WO2007116654

The invention claimed is:
 1. A faster method of orthodontic remodeling,comprising: a) a patient wearing an orthodontic appliance biting anorthodontic remodeling device, said orthodontic remodeling devicecomprising: i) an extraoral housing containing a power source operablycoupled to an actuator operably coupled to a processor that thatcontrols said actuator and captures and communicates device usage data;ii) said extraoral housing operably connected to an intraoral U-shapedbite plate; iii) said bite plate having upper and lower vertical rims ona facial edge thereof to contact both arches of teeth; and iv) whereinduring use said orthodontic remodeling device is held in place only byteeth clamping on the bite plate and said orthodontic remodeling devicevibrates at a frequency from 0.1 to 400 Hz; and b) activating saidorthodontic remodeling device for about 20 minutes daily; wherein saidmethod provides accelerated tooth movement as compared to without usingsaid orthodontic remodeling device.
 2. The method of claim 1, whereinsaid power source is a battery.
 3. The method of claim 2, wherein saidbattery is a rechargeable battery.
 4. The method of claim 2, whereinsaid battery is a rechargeable battery that is charged from a USB port.5. The method of claim 1, wherein said orthodontic appliance comprisesbraces.
 6. The method of claim 1, wherein said orthodontic appliancecomprises an aligner.
 7. The method of claim 1, said bite plate havingupper and lower vertical rims on a lingual edge thereof.
 8. The methodof claim 1, wherein said orthodontic remodeling device automaticallyshuts off after 20 minutes.
 9. The method of claim 1, wherein saidorthodontic remodeling device vibrates at 30 Hz and 0.2 N and saidaccelerated tooth movement is about 0.5 mm per week.